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Completed Phase 3 Interventional Results available

Study of Diclofenac Capsules to Treat Osteoarthritis Pain

ClinicalTrials.gov ID: NCT01461369

Public ClinicalTrials.gov record NCT01461369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 4:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Study identification

NCT ID
NCT01461369
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Iroko Pharmaceuticals, LLC
Industry
Enrollment
305 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2011 (Type not available)
Primary completion
Mar 2012 (Actual)
Completion
Oct 2012 (Actual)
Last update posted
May 26, 2014

2011 – 2012

United States locations

U.S. sites
40
U.S. states
20
U.S. cities
34
Facility City State ZIP Site status
Premier Research Group - Phoenix Phoenix Arizona 85027 —
Lynn Institute of the Ozarks Little Rock Arkansas 72205 —
Acri-Phase I, LLC Anaheim California 92801 —
Med Center Carmichael California 95608 —
Expresscare Clinical Research Colorado Springs Colorado 80909 —
Westside Center for Clinical Research Jacksonville Florida 32205 —
Jacksonville Center for Clinical Research Jacksonville Florida 32216 —
Well Pharma Medical Research, Corporation Miami Florida 33143 —
Peninsula Research, Inc Ormond Beach Florida 32174 —
Alliance Clinical Research Winter Park Florida 32792 —
Pinnacle Trials, Inc Atlanta Georgia 30329 —
Drug Studies America Marietta Georgia 30060 —
Clinical Investigation Specialists, Inc Gurnee Illinois 60031 —
Heartland Research Associates, LLC Newton Kansas 67114 —
Clinical Trials Technology Inc Prairie Village Kansas 66206 —
Professional Research Network of Kansas, LLC Wichita Kansas 67203 —
Community Research Crestview Hills Kentucky 41017 —
Quest Research Institute Bingham Farms Michigan 48025 —
Healthcare Research Florissant Missouri 63031 —
Sundance Clinical Research, LLC St Louis Missouri 63141 —
Heartland Clinical Research, Inc Omaha Nebraska 68134 —
Meridian Clinical Research Omaha Nebraska 68134 —
Office of Matthew Barton, MD Las Vegas Nevada 89106 —
Drug Trials America Hartsdale New York 10530 —
Clinical Study Center of Asheville, LLC Asheville North Carolina 28803 —
Triad Clinical Research Greensboro North Carolina 27408 —
Peters Medical Research High Point North Carolina 27262 —
Sterling Research Group, Ltd Cincinnati Ohio 45219 —
Community Research Cincinnati Ohio 45227 —
Community Research Cincinnati Ohio 45245 —
Sterling Research Group, Ltd Cincinnati Ohio 45246 —
Radiant Research, Inc Columbus Ohio 43212 —
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 —
Radiant Research, Inc Anderson South Carolina 29621 —
Premier Research Group - Austin Austin Texas 78705 —
Clinical Investigations of Texas, LLC Plano Texas 75075 —
Quality Research Inc San Antonio Texas 78209 —
Progressive Clinical Research San Antonio Texas 78229 —
Charlottesville Medical Research Center, LLC Charlottesville Virginia 22911 —
Hypothetest, LLC Roanoke Virginia 24018 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01461369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 26, 2014 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01461369 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →